Proneuron Biotechnologies announced today that the US Food and Drug Administration (FDA) has granted an orphan drug designation to ProCord, autologous incubated macrophage therapy, to improve the motor and sensory neurological outcome in cases of acute spinal cord injury.
In the U.S. alone, there are an estimated 11,000 new spinal cord injuries per year.
Orphan drug status is granted by the FDA Office of Orphan Products Development (OOPD) to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In order to qualify as an orphan drug, a product must target conditions that affect less than 200,000 people a year in the U.S. and that should offer substantially improved therapeutic benefit as compared to current medical regimens. Orphan drug designation provides for seven years of market exclusivity in the U.S. to the first entity that obtains marketing approval in the designated indication. Other benefits to the sponsor include tax credits for the costs of clinical research, reduced filing fees and preferential pre-filing regulatory guidance.